[Federal Register: April 15, 2002 (Volume 67, Number 72)]
[Notices]
[Page 18205-18206]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ap02-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Notice of Meetings: Secretary's Advisory Committee on Genetic
Testing
Pursuant to Public Law 92-463, notice is hereby given of two
meetings of the Secretary's Advisory Committee on Genetic Testing
(SACGT), U.S. Public Health Service. An education conference, Genetic
Testing and Public Policy: Preparing Health Professionals, will be held
from 8:30 a.m. to 5 p.m. on May 13, 2002. SACGT's thirteenth meeting
will be held from 9 a.m. to 5:30 p.m. on May 14, 2002 and 8 a.m. to
2:30 p.m. on May 15, 2002. Both meetings will be held at the Hyatt
Regency, 300 Light Street, Baltimore, MD and are free and open to the
public with attendance limited to space available. Pre-registration is
encouraged for the May 13 education conference. Online registration for
the May 13 conference is available at http://www4.od.nih.gov/oba/
sacgt.htm or by calling Abbe Smith at 301-897-7423. A catered luncheon
is offered on May 13 at a cost of $30 and requires advance
registration.
The one-day education conference will consider the challenges of
integrating genetic testing into clinical and public health practice
for the wide range of health professionals likely to be affected by
this expanding field.
[[Page 18206]]
Through a combination of plenary presentations and panel discussions,
the conference will explore the integration of genetics into primary
care and discuss the various roles of healthcare providers in the
provision of genetics services. Afternoon focus groups will concentrate
on several different areas of genetics education, training, and
integration. Conference participants will be asked to consider a number
of public policy questions of interest to SACGT, including how are
health professions schools responding to changes and challenges brought
about by genetics and genetic testing; are future health professionals
being taught what they need to know to integrate new health
technologies and services into the clinical and public health settings;
are current health professionals, who were trained long long before the
explosion of genetics knowledge, receiving the training they need to
continue to practice effectively; are they being taught about the
proper use and interpretation of genetic tests and about their ethical,
legal, and social implications; are the revolutionary advances in
genetics having an equally revolutionary effect on our educational
methods; what changes are already underway; are they sufficient; are
they occurring quickly enough; is government doing as much as it should
do? On the following day during its regular Committee meeting, SACGT
will consider these issues and develop its recommendations to the
Secretary.
Reviewing the outcomes of the SACGT Education Conference will be
the Committee's first order of business at its May 14-15 meeting. In
addition, four of the SACGT work groups will be presenting reports to
the Committee: The ACCESS Work Group will present a draft report on
billing and reimbursement for genetic education and counseling
services; the Informed Consent/Institutional Review Board Work Group
will present its revised recommendations on decision making and
informed consent for clinical and public health genetic tests; the Data
Work Group will present three case studies on the development and
clinical application of a genetic test; and the Rate Disease Work Group
will present a report on genetic testing for rare diseases.
Presentations will also be made on the development of a ``Frequently
Asked Questions'' document on Clinical Laboratory Improvement
Amendments certification and the Food and Drug Administration's
progress in the development in the development of a pre-market review
of genetic tests. Time will be provided for public comment and
interested individuals should notify the contact person listed below.
Under authority of 42 U.S.C. 217a, Section 222 of the Public Health
Service Act, as amended, the Department of Health and Human Services
established SACGT to advise and make recommendations to the Secretary
through the Assistant Secretary for Health on all aspects of the
development and use of genetic tests. SACGT is directed to (1)
recommend policies and procedures for the safe and effective
incorporation of genetic technologies into health care; (2) assess the
effectiveness of existing and future measures for oversight of genetic
tests; and (3) identify research needs related to the Committee's
purview.
The draft meeting agenda and other information about SACGT will be
available at the following Web site: http://www4.od.nih.gov/oba/sacgt/
htm. Individuals who wish to provide public comment or who plan to
attend the meeting and need special assistance, such as sign language
interpretation or other reasonable accommodations, should notify the
SACGT Executive Secretary, Ms. Sarah Carr, by telephone at 301-496-9838
or e-mail at sc112@nih.gov. The SACGT office is located at 6705
Rockledge Drive, Suite 750, Bethesda, Maryland 20892.
Dated: April 5, 2002.
Sarah Carr,
Executive Secretary, Secretary's Advisory Committee on Genetic Testing.
[FR Doc. 02-9092 Filed 4-12-02; 8:45 am]
BILLING CODE 4140-01-M